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GALLANT 22 Tesaglitazar vs. Placebo

NCT00252837 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2008-03-17

No results posted yet for this study

Summary

This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period.

The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.

Conditions

Interventions

DRUG

Tesaglitazar

BEHAVIORAL

Dietary and Lifestyle counseling

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Galida Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Completion
2006-12-31

Countries

  • Australia
  • Czechia
  • Estonia
  • France
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Norway
  • Philippines
  • Poland
  • Serbia and Montenegro
  • Slovakia
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00252837 on ClinicalTrials.gov